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Completed

NCT Number: NCT01951534

Decisional Aid Intervention for Women Considering Breast Reconstruction

This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes.

The primary aim of this study is: "Is the intervention trial feasible?" The purpose is to develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is important that this trial provide evidence of feasibility. The investigators will define feasibility as the rate of study acceptance and participation.

The secondary aim of this study is: " Is the BRDA acceptable and used?" The team will evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict uptake and use. The investigators anticipate that, due to interest in the topic, the majority of women will access the website.

An additional secondary aim of this study is: "What is the impact of BRDA on BR knowledge, attitudes about BR, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with oncologist?" The purpose is to calculate effect sizes for a larger randomized trial.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ocean Medical Center, Brick, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is scheduled for a surgical consult with a breast surgeon
  • Primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
  • Patient speaks and reads English
  • Patient is considering mastectomy

Exclusion criteria

  • Patient who selects lumpectomy and not mastectomy

Treatment and study plan

Breast Reconstruction Decisional Aid (BRDA)

Behavioral

Usual Care

Behavioral

Primary outcomes

  1. Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction

    Time frame: 3 years

    We will define feasibility as the rate of study acceptance and participation. First, we will examine acceptance as determined by consents and completed baselines. Second, we will examine time for completing surveys. We will judge this trial feasible if: 1) the acceptance rate among eligible patients is equal to or greater than 70%. We will judge completion rates at follow-up to be feasible for a larger scale trial if our completion rate is 75%. 2) If the survey length averages are > 35 minutes, we will deem this unacceptable and shorten the survey.

Secondary outcomes

  1. Acceptability of BRDA

    Time frame: 3 years

    We will define acceptability using both quantitative and qualitative methods. Basic descriptive information will be automatically gathered from the DA tracking system regarding whether participants logged in, how many times, and for how long. Time spent in each module will be tracked and summarized. Participants will rate the DA and provide interview feedback regarding its ease of use. Interview feedback regarding home versus public access will be gathered. A second indicator of acceptability will be ratings on the DA evaluation and interview. The range of items on the scale is 1-7. An item mean of 4 is mid-range. We judge our intervention as acceptable if 75% of BRDA participants used the DA and if the average score on the evaluation was > 5.6, which is 80% of the highest score.

  2. Impact of breast reconstruction decisional aid on knowledge and attitudes

    Time frame: 3 years

    This is an exploratory objective to calculate effect sizes for a larger randomized trial. Using survey data that we will collect as part of this research, we will look at the impact of BRDA on knowledge and attitudes.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey

Registry information

Acronym: BRDA

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Sep 26, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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